The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

29551–29575 of 50499

  • HighFDA (Devices)·Z-1146-2018·2018-03-28

    Vascular Insights Recalls ClariVein IC Infusion Catheters Due to Manufacturing Defect

    Vascular Insights is recalling 928 ClariVein IC infusion catheters because a manufacturing defect may cause the catheter shaft to delaminate.

    Product
    ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0981-2018·2018-03-28

    Oregon Food Bank Recalls Chia Seeds Contaminated With Rodent Droppings

    Oregon Food Bank is recalling 1 lb. packages of chia seeds due to contamination with rodent droppings. The product was distributed in Oregon and Washington.

    Product
    Chia Seeds packaged in poly film bags as both a twist type closure and a re-sealable pouch, net wt. 1 lb.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·18V194000·2018-03-26

    Daimler Trucks Recalls 2018-2019 Freightliner Custom Chassis XCS Vehicles

    Daimler Trucks North America is recalling 2018-2019 Freightliner Custom Chassis XCS motorhome chassis because a valve stem stabilizer may dislodge, potentially causing tire damage and increasing crash risk.

    Product
    FCCC — FCCC XCS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V197000·2018-03-23

    Lazy Daze Recalls Motorhomes with Defective Fire Extinguishers

    Lazy Daze is recalling 2012-2017 motorhomes because certain fire extinguishers may clog or detach, potentially failing to work during a fire.

    Product
    LAZY DAZE — LAZY DAZE 27' MID-BATH (27MB), 27' REAR BATH (27RB), 24' FRONT DINETTE(24FD), 27' REAR KITCHEN (27RK)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18129·2018-03-22

    SpeeCo and Woods Recall 4-Way Wedge Accessory for Log Splitters

    SpeeCo and Woods are recalling 4-way wedge accessories for hydraulic log splitters because they can detach and strike users, causing injury.

    Product
    4-way wedge accessory for hydraulic log splitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling three Proteus 235 proton therapy systems because the internal configuration of electrometers and control boards is not checked before each patient treatment.

    Product
    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2018·2018-03-21

    Alden Classic 38 Sphere Daily Wear Soft Contact Lenses Recalled for Sterility Issues

    Alden Optical is recalling Alden Classic 38 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the United States and Canada.

    Product
    Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2018·2018-03-21

    Ortho Solutions Recalls System 26 Implants Due to Corrosion Residue

    Ortho Solutions is recalling 106 System 26 Forefoot and Midfoot implant trays from the US market because corrosion residue was found inside the cannulated devices.

    Product
    SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V186000·2018-03-21

    Forest River Cherokee Recalled for Propane Leak Fire Risk

    Forest River is recalling 2017-2018 Cherokee recreational trailers because a loose propane valve screw may allow gas to leak, increasing the risk of fire.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2018·2018-03-21

    Alden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

    Product
    NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2018·2018-03-21

    Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns

    Zimmer Biomet is recalling TunneLoc Tibial Fixation Devices because testing suggests the sterilization dose may be inadequate. The devices are distributed nationwide.

    Product
    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 14 Proteus 235 proton therapy systems because an accessory can be improperly inserted, allowing the device to operate incorrectly.

    Product
    Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions…
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·18E016000·2018-03-21

    BMW Recalls Accessory Motorcycle Windscreens Due to Visibility Issues

    BMW is recalling specific accessory windscreens for various motorcycle models because extra tinting may reduce rider visibility, increasing crash risk.

    Product
    BMW — BMW R1200 R, S1000 R, S1000 XR, F700 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2018·2018-03-21

    Alden Optical Recalls HP59 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling HP59 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0925-2018·2018-03-21

    Plant Divas Lemongrass Facial Polish Recalled for Microbial Contamination

    Plant Divas Inc. is recalling Lemongrass Facial Polish with Oats, Fengreek & Neem because FDA testing found excessive numbers of microorganisms.

    Product
    Lemongrass Facial Polish with Oats, Fengreek & Neem. 3 oz cylindrical box evanhealy Hand Made in CA by Plant Divas Inc., San Diego, CA 92064
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2018·2018-03-21

    Medimop Recalls Vial2Bag DC Devices Due to IV Port Separation Risk

    Medimop is recalling specific lots of Vial2Bag DC devices because the IV Port may separate from the body during use.

    Product
    Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0976-2018·2018-03-21

    Deerfield IMRIS T2X Table Recall Due to Rotational Locking Defect

    Deerfield Imaging is recalling 16 IMRIS T2X tables because the rotational locking mechanisms can disengage, potentially causing unintended table movement.

    Product
    IMRIS T2X Table, Part Number 109682-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0993-2018·2018-03-21

    Zimmer Biomet Recalls Juggerknot 2.9mm Suture Anchors for Hip Arthroplasty

    Zimmer Biomet is recalling 50 units of Juggerknot 2.9mm suture anchors used in hip arthroplasty. The recall is limited to the state of Texas.

    Product
    JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0938-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 37 Proteus 235 Proton Therapy Systems due to a risk of patient misalignment when using treatment plans with multiple isocenters.

    Product
    Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1065-2018·2018-03-21

    Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation

    Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.

    Product
    ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2018·2018-03-21

    3M Recalls Ankle Braces Due to Missing Latex Warning Label

    3M is recalling specific ACE and Futuro ankle braces because they contain natural latex rubber but lack the required caution statement.

    Product
    ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
    Category
    Medical Device
    Distribution
    0 states